Contract research, development, and manufacturing organizations (CRO/CDMOs) are well established in the drug development lifecycle and are often used for dedicated activities along the drug discovery and preclinical development process. Each of these main areas (discovery and development) of the drug development process breaks into specific areas. These areas can include target identification, target validation, lead identification, early pharmacology, high throughput screening (HTS), adsorption, distribution, metabolism, and excretion (ADME), drug metabolism and pharmacokinetics (DMPK), bioanalysis, formulations, safety/toxicity, process development, and scale up, etc. Domain specialist CROs have emerged in this space as well as larger “platform” CROs who offer full “end-to-end” service.

The shift to large molecule/biologics as drug candidates has been occurring for the past 10–15 years (1)—the trend often attributed to the success of Herceptin, Genentech’s blockbuster treatment for certain types of breast cancer. Many pharma and biotech companies have looked to mimic this success, as evidenced by the increase in new drug applications for biologic-based drugs, year-on-year for 10 years. As companies rapidly change their focus, they may lack the laboratory space, instrumentation, and often, the scientific domain knowledge to support biologics research without a huge resource investment.

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When referring to this article, please cite it as P. Denny-Gouldson, "Barriers and Solutions to Effective External Collaboration in Biopharma," BioPharm International Biopharma Laboratory Best Practices eBook (October 2018).